Systems and methods for remote manufacturing of medical devices

ABSTRACT

A system and method for remote manufacturing of medical devices are provided. The system can be installed at a facility (e.g., at a hospital or other medical facility), and includes a remote manufacturing unit (RMU) that allows for customized, rapid fabrication of medical devices at the medical facility using suitable manufacturing techniques such as three-dimensional (3D) printing, additive manufacturing, subtractive manufacturing, etc. The RMU can communicate with a computer system which presents a healthcare professional with a digital catalog of medical products, and allows the healthcare professional to select and customize a desired device to be manufactured at the facility.

BACKGROUND Field of the Invention

The present invention relates to the manufacturing of medical devices.More particularly, the present invention relates to systems and methodsfor remote manufacturing of medical devices.

Related Art

In the medical device industry, rapid design and fabrication ofcomponents is paramount. Not only must products be manufactured inaccordance with stringent standards, they must also be manufacturedsufficiently quickly to meet customer demands. Remote manufacturing ofmedical devices has been explored in the orthopedics space, but has metwith limited success. In the past, several factors contributed to thelimited success of such efforts, but implant design issues remain thelargest obstacle.

In the mechanical engineering space, robust technologies exist and arebeing developed which allow for the rapid prototyping and manufacturingof components, such as three-dimensional (3D) printing of components,interchangeably referred to as additive manufacturing, and othertechniques. While these technologies are finding use in various fieldsof endeavor, to date, there has been limited success applying suchtechnologies to the fabrication of medical components. Manufacturing ofsuch devices has several advantages over traditional medical devicemanufacturing methods, including, but not limited to, reduction in cost,capability for customization, unique manufacturing capabilities,reduction in the number of machines required to manufacture a device,and reduction in human resources required to manufacture a device.

It would also be beneficial to manufacture medical devices at remotefacilities, including but not limited to medical facilities, using theforegoing techniques. By providing the capability to remotelymanufacture medical devices at remote locations, further advantagescould be realized, including reduction in shipping costs, reduction incorporation inventory, more potential for customization of medicaldevices, and reduction in corporation manufacturing equipment.

Accordingly, it would be desirable to provide systems and methods forremote manufacturing of medical devices which address the foregoingneeds.

SUMMARY

The present disclosure relates to systems and methods for remotemanufacturing of medical devices. One such system can be installed at amedical facility (e.g., at a hospital), and includes a remotemanufacturing unit (RMU) that allows for customized, rapid fabricationof medical devices at the medical facility using suitable manufacturingtechniques such as additive manufacturing, subtractive manufacturing,etc. The RMU can communicate with a kiosk-type computer system installedat the medical facility which presents a healthcare professional with adigital catalog of medical products, and allows the healthcareprofessional to select and customize a desired device to be manufacturedat the facility. The kiosk can also display a model of the device to befabricated, allowing the healthcare professional to customize variousparameters of the device prior to fabrication. The same functionalityprovided by the kiosk computer can also be provided on a portablecomputing device in communication with the system, such as a laptopcomputer, personal computer, tablet computer, smart phone, or other typeof computing device, allowing healthcare professionals at variouslocations to access the system and select/specify devices to bemanufactured at a medical facility. A central control system could alsobe provided, which controls manufacturing processes carried out bymultiple RMUs at various locations, and which allows for remote qualitycontrol/inspection by personnel remote from the medical facility. Thesystem can also communicate with a hospital information managementsystem to update patient records, schedule surgeries, and processbilling relating to manufacturing of medical devices.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing features of the invention will be apparent from thefollowing Detailed Description, taken in connection with theaccompanying drawings, in which:

FIG. 1 is a diagram showing a remote manufacturing system of the presentinvention for manufacturing medical devices at a medical facility;

FIG. 2 is a diagram showing hardware components of the remotemanufacturing unit of FIG. 1 in greater detail;

FIGS. 3A-3E are screenshots showing user interface screens generated bythe system for allowing a user to browse through a digital catalog ofmedical devices, to select a desired device for fabrication at a medicalfacility, and for customizing a device prior to fabrication;

FIG. 4 is a flowchart showing processing steps carried out by the systemfor fabricating a medical device at a medical facility;

FIG. 5 is a flowchart showing processing steps carried out by the systemfor allowing a healthcare professional to customize a device prior tofabrication of same;

FIG. 6 is a flowchart illustrating processing steps carried out by thesystem for transmitting instruction files for fabricating a medicaldevice to the remote manufacturing unit of the system, and forprocessing same at the remote fabrication unit;

FIG. 7 is a flowchart showing additional processing steps carried out bythe system for manufacturing a medical device at a medical facility;

FIG. 8 is a flowchart showing processing steps carried out by the systemfor periodic calibration of the remote manufacturing unit of the system;

FIG. 9 is a diagram illustrating hardware and software components of theremote manufacturing unit controller of the system;

FIG. 10 is a diagram illustrating hardware and software components ofthe central control system of FIG. 1; and

FIG. 11 is a diagram illustrating hardware and software components of asmartphone programmed in accordance with the present disclosure.

DETAILED DESCRIPTION

The present disclosure relates to systems and methods for remotemanufacturing of medical devices, as discussed in detail below inconnection with FIGS. 1-11.

FIG. 1 is a diagram illustrating a system 10 according to the presentdisclosure for remote manufacturing of medical devices. The system 10includes a remote manufacturing unit (RMU) 12 installed at a medicalfacility 14 (e.g., at a hospital) which allows for on-demandmanufacturing of medical devices at the facility 14, such as orthopedicimplants (e.g., hip implants, knee implants, etc.), surgicalinstrumentation to be used by a surgeon to install implants, and othermedical devices. As will be discussed in greater detail below, the RMU12 includes a number of subsystems which allow for rapid, on-sitemanufacturing of devices and instrumentation at the medical facility 14using suitable manufacturing techniques such as additive manufacturing,subtractive manufacturing, etc.

Optionally, a computer kiosk 16 could be provided at the facility 14 forallowing a user, such a surgeon, to browse through a digital catalog ofmedical implants and/or instrumentation, to select desired devices to befabricated, to customize such devices, and to order such devices andschedule them for manufacturing at the medical facility 14 by the RMU12. The kiosk 16 could include a touch-screen user interface forallowing simple and convenient user interaction, a trackball, and/orother suitable user input devices. The kiosk 16 is in communication withthe RMU 12 (e.g., by a wired or wireless communication network at thefacility 14). Additionally, the RMU 12 and the kiosk 16 could both be incommunication with a central control system 20 via a network 18 such asthe Internet. Additionally, the RMU 12 and the kiosk 16 could be incommunication with one or more mobile computing devices operated bydoctors and/or patients, such as smart phones 26, and the kiosk 16 couldbe in communication with a hospital information management system 28.The smart phones 16 could include any type of smart phone such as, butnot limited to, an APPLE IPHONE, or any other type of smart phone suchas, but not limited to, phones operating the DROID operating system,etc.

The digital catalog of medical devices can be accessed at the kiosk 16,and it can also be accessed using one or more of the smart phones 26(e.g., using a web browser or a software application (“app”) installedon the smart phones 26). Moreover, the digital catalog can be accessedusing a computer having access to the network 18 (such as a personalcomputer, laptop computer, tablet computer (e.g., APPLE IPAD), etc.). Aswith the kiosk 16, a doctor can use a smart phone 26 to select a medicaldevice to be manufactured, customize the device, and specify a desiredtime for manufacturing the device at the facility 14. The digitalcatalog can be hosted on one or more remote servers, such as servers 24of the control system 20, and can be accessed by the kiosk 16 and thesmart phones 26. Alternatively, the digital catalog can be installed onthe kiosk 16 and/or the smart phones 26, and periodically updated.

The control system 20 includes one or more servers 22 for remotelymonitoring and controlling fabrication of medical devices by the RMU 12,and allows for remote control and management of multiple RMUs located atdifferent locations, thereby providing a remotely-controlled,manufacturing network that can extend across multiple locations, e.g.,at multiple medical facilities. Also, as discussed in greater detailbelow, the control system 20 maintains records of manufacturingperformed by the RMU 12, manufacturing deviations requiring review, suchas by a human operator (e.g., by a product designer, engineer, etc.) orotherwise, and for periodically performing calibration of the RMU 12.The servers 24 could provide a central repository or store of medicaldevice designs that can be updated in real time and accessed via thedigital catalog.

Optionally, communication with a hospital information management system28 could be provided so that access to patient information, billinginformation, and patient surgery schedules is provided to the system 10.This allows the system 10 to coordinate manufacturing of devices by theRMU 12 to accommodate surgery schedules, to allocate devices to patientrecords, and to process patient billing associated with fabricatedmedical devices.

FIG. 2 is a diagram showing hardware components of the RMU 12 of FIG. 1in greater detail. The RMU 12 includes a controller 30 and a number ofsub-systems 32-40 which perform various functions associated withmanufacturing of a desired medical device at a remote facility such as amedical facility. The controller 30 and sub-systems 32-40 could beprovided within a single housing of the RMU 12, or they could beprovided separately but interconnected to each other. The RMU controller30 is a specially-programmed, general purpose computer system (e.g., anembedded computer system) which controls all aspects of operation of theRMU 12, including overall control for fabrication, inspection,cleaning/sterilization, and packaging functions performed by the RMU 12.The RMU controller 30 communicates with and controls each of thesub-systems 34-42, discussed in detail below.

The RMU controller 30 communicates with a network communicationsubsystem 32, which permits communication between the RMU 12 and one ormore external systems, such as the kiosk 16, the central control system20, one or more of the smart phones 26, and/or the hospital informationmanagement system 28. The network communications subsystem 32 could be awired or wireless network communications subsystem, such as a wired orwireless Ethernet transceiver, and allows the RMU 12 to receive externalinformation such as commands and/or instruction files for fabricatingdesired medical devices, as well as to transmit information to the kiosk16, the central control system 20, and/or the smart phones 26 such asstatus information regarding fabrication processes being carried out bythe RMU 12, alert notifications, request for calibration of the RMU 12,etc.

The RMU 12 includes a manufacturing subsystem 34 in communication withthe RMU controller 30, which allows for on-site (e.g., at a medicalfacility) manufacturing of medical devices using suitable fabricationtechniques. Such techniques include, but are not limited to, additivemanufacturing, subtractive manufacturing, and any other suitabletechniques. The manufacturing subsystem 34 is controlled by the RMUcontroller 30, and instructed by the RMU controller 30 to manufacturedesired medical devices using information received by the RMU controller30 via the network communications subsystem 32. Devices can befabricated by the manufacturing subsystem 34 using any suitablematerials, such as, but not limited to, polymeric materials (e.g.,polyetherketoneketone (PEKK), etc.), metallic alloys (e.g., titanium,stainless steel, cobalt-chromium, etc.), or other suitable materials.The manufacturing subsystem 34 can manufacture medical devices ofvarious types, including, but not limited to, implants (orthopedic,spinal, trauma, microfixation, etc.) and instrumentation (retractors,inserters, trials, etc.)

The RMU 12 also optionally includes a cleaning/sterilization subsystem36 which performs initial and final cleaning of devices manufactured bythe manufacturing subsystem 36, as well as passivation and sterilizationof such devices. An optional packaging subsystem 38 is also provided inthe RMU 12, and receives final (sterilized) devices from thecleaning/sterilization subsystem 36 and packages same for distributionto an operating room or other location within the medical facility. Thepackaging subsystem 38 could deliver the completed package to amaterials distribution system within the medical facility, such as apneumatic tube system, an electric track vehicle (ETV) system within themedical facility, etc., so that the completed package can beautomatically delivered to a desired location (e.g., operating room)within the medical facility.

The RMU 12 also optionally includes a robotic integration subsystem 40and an inspection subsystem 42. The robotic integration subsystem 40allows for automatic (robotic) physical transfer of a medical devicefrom the manufacturing subsystem 34, to the inspection subsystem 42 and,if the device passes inspection, thereafter to the cleaning subsystem 36and the packaging subsystem 38. The inspection subsystem 42 inspectsdevices manufactured by the manufacturing subsystem 34, using anysuitable inspection technique such as non-contact (e.g., laser)scanning, or other technique(s). If the fabricated device does not passinspection standards, the inspection subsystem 42 communicates an alertto the RMU controller 30, and the RMU controller 30 then transmits thealert to the central control system 20 for intervention and handling ofthe issue, such as by a quality control engineer or other personnel, aswill be discussed in greater detail below.

As noted above, each of the components 30-42 could be provided within asingle equipment housing of the RMU 12. Preferably, such a housingprovides a sterile environment in which all fabrication processes occur.Of course, separate housings could be provided for each of thecomponents 30-42 shown in FIG. 2, if desired. Further, each of thecomponents 30-42 could communicate using a common communications businterconnecting the components 30-42, such as a controller area network(CAN), a serial network (e.g., RS-485), or any other suitable type ofcommunications network.

FIGS. 3A-3E are screenshots showing user interface screens generated bythe system for allowing a user to browse through a digital catalog ofmedical devices, to select a desired device for fabrication at a medicalfacility, and for customizing a device prior to fabrication. The screensgenerated by the system provide a rich, interactive environment for useby a healthcare professional for specifying, customizing, and submittingdevice orders for subsequent manufacture of such devices on-site, suchas at a medical facility by the RMU 12 of FIGS. 1-2. The screensdiscussed herein could be displayed by the kiosk 16 of FIG. 1, as wellas by one or more of the smart phones 26 shown in FIG. 1 (e.g., using asoftware “app” installed on the smart phones 26) or using any othersuitable type of computing device capable of communicating via thenetwork 18 of FIG. 1, such as a desktop computer, a laptop computer,tablet computer, etc. Together, the screens shown in FIGS. 3A-3E providea simple, easy-to-use digital catalog that a healthcare professionalsuch as a doctor, surgeon, etc., can use at any desired location inorder to order and/or customize medical devices to be manufactured onsite at a remote facility, such as a medical facility.

FIG. 3A is a screenshot showing an initial screen 50 generated by thesystem. The screen 50 allows a user to select from a plethora ofpre-defined device categories in the digital catalog, in order to selecta desired device to be fabricated. As shown, a plurality of “buttons” 52a-52 h could be provided, and the user can select a desired productcategory by touching or clicking on the corresponding button. As shown,the buttons 52 a-52 h could allow the user to select from one or moreproduct categories, including, but not limited to, orthopedics implants,spinal implants, trauma implants, microfixation implants, orthopedicinstrumentation, spinal instrumentation, trauma instrumentation, and/orother types of product categories.

FIG. 3B is a screenshot showing a second screen 54 generated by thesystem. The screen 54 is displayed when the user selects the orthopedicimplants product category of FIG. 3A by clicking on the button 52 a. Ascan be seen, the screen 54 allows the user to select from a plurality oforthopedic implants by clicking on one of the buttons 56 a-56 d. Theuser can select a hip implant, a knee implant, an extremity implant, oranother (miscellaneous) type of implant.

FIG. 3C is a screenshot showing a third screen 58 generated by thesystem. The screen 58 is displayed when the user selects the “KneeImplants” button 56 b of FIG. 3B. As can be seen, the screen 58 allows auser to select a desired type of knee implant to be fabricated byclicking on one of the buttons 60 a-60 g. Examples of the types of kneeimplants that could be fabricated at the medical facility include, butare not limited to, a complete knee system, an antioxidant infused kneeimplant, a porous titanium construct, a revision knee system, a tibialsystem, a patellofemoral replacement system, and/or a partial kneesystem.

FIG. 3D is a screenshot showing a user interface screen 62 generated bythe system, for allowing a healthcare professional to customize adesired implant for fabrication by the system. The screen 62 displays atwo- or three-dimensional model 64 of the device to be fabricated (inthis case, a total knee replacement as shown in FIG. 62). The model 64can be updated as desired by the healthcare professional using one ormore parameter adjustment fields 66 a-66 d. Parameters that can beupdated include, but are not limited to, dimensions of the device to befabricated, materials, etc. When the desired parameters have beenupdated, the user can click on the “Update Model” button 68, whereuponthe model of the device to be fabricated is updated, and the updates aredisplayed in the model 64 so that the operator can visualize the updatesrequested. When the desired updates have been made, the user can clickon the “Next” button 70.

FIG. 3E is a screenshot showing a user interface screen 72 generated bythe system. In this screen, the healthcare professional can enterinformation about the patient, and can also schedule a desired surgerydate. Various data entry fields 74 a-74 e can be provided for enteringinformation including, but not limited to, patient name (field 74 a),hospital (field 74 b) at which the device is to be fabricated and/or atwhich surgery is to take place, name of the patient's primary doctor(field 74 c), name of the surgeon performing the surgery using thedevice to be fabricated (field 74 d), and scheduled surgery date 74 e.The system 10 can communicate this information to a hospital informationmanagement system (such as the system 28 of FIG. 1) so that thepatient's hospital records are updated and so that the surgery isscheduled with the hospital. The user can click on the “Clear” button 76to clear the fields and to re-enter information, if desired. The“Finish” button 78 can be clicked by the user when the patient andsurgery information has been entered.

FIG. 4 is a flowchart showing processing steps 80 carried out by thesystem for allowing a healthcare professional to browse through thedigital device catalog of the system, select a desired medical devicefor fabrication at a facility (e.g., at a hospital), customize thedevice, and to fabricate the device at a facility using the RMU of thesystem. Beginning in step 82, the system displays the device catalog toa healthcare professional. The catalog could be displayed using thekiosk 16 or one or more of the smart phones 26 of FIG. 1, or using acomputing device in communication with the network 18, such as apersonal computer having a web browser, laptop computer, or tabletcomputer. In step 84, the healthcare professional selects a device to bemanufactured from the catalog, and in step 86, the healthcareprofessional customizes the selected device, e.g., as discussed above inconnection with FIGS. 3A-3D. Then, once the device has been customized,step 88 occurs, wherein the healthcare professional schedules a surgerydate for a patient using the system (e.g., as discussed above inconnection with FIG. 3E). In step 90, a determination is made as towhether additional devices are to be selected/customized by thehealthcare professional (e.g., one or more instruments to be fabricatedfor use in installing a medical device). If so, processing returns tostep 82 so that additional devices can be fabricated; otherwise, controlpasses to step 92.

In step 92, the system electronically communicates information about thedevice to be fabricated to the RMU 12. Then, in step 94, the RMU queuesthe medical device request so that fabrication of the device occurs atan appropriate time, e.g., in sufficient time so that the device isready for use at on the scheduled surgery date. In step 96, afterqueuing, the RMU manufactures the device at the medical facility. Instep 98, once the device has been fabricated by the RMU, it is packaged.Then, in step 100, the device is shipped to an operating room (OR) orother desired location within the medical facility for use by thehealthcare professional, e.g., during an operation scheduled by thehealthcare professional. Finally, in step 102, a notification istransmitted by the RMU to the central control system 20 of FIG. 1,indicating that the device was successfully manufactured.

FIG. 5 is a flowchart showing, in greater detail, processing steps 110carried out by the system for allowing a healthcare professional tocustomize a device for fabrication. In step 112, a model of the deviceis displayed to the healthcare professional (e.g., as shown in FIG. 3D),and the healthcare professional varies one or more parameters of thedevice, such as dimensions, materials, etc. Then, in step 114, once theparameters have been entered, the model is updated. In step 116, adetermination is made as to whether further modification of the deviceis desired. If so, control returns to step 112; otherwise, controlpasses to step 118.

In step 118, a determination is made as to whether verification of theupdated design is required. If not, processing shown in FIG. 5 ends.Otherwise, step 120 occurs, wherein the updated design is transmitted topersonnel (e.g., engineering personnel, quality control personnel,etc.). Then, in step 122, a determination is made as to whether theupdated design is verified. If so, processing in FIG. 5 ends. Otherwise,step 124 occurs, wherein the system transmits an alert to the healthcareprofessional indicating that the updated design is not suitable formanufacturing. In such circumstances, the healthcare professional canchange the design using the system, if desired.

FIG. 6 is a flowchart showing processing steps 130 carried out by thesystem for processing of device manufacturing orders by the RMU. In step132, the system transmits a device manufacturing instruction file to theRMU. Then, in step 134, the system transmits order information to anoperator of the system for, e.g., recordkeeping, billing, and/or otherpurposes. In step 136, the system transmits an update to a patientinterface (e.g., a web-based or app-based interface running on acomputer system in communication with the system 10, such as the smartphones 26 of FIG. 1), so that the patient can monitor the status offabrication of a medical device.

FIG. 7 is a flowchart showing additional processing steps 140 carriedout by the system for manufacturing a medical device at a facility, suchas a medical facility. In step 142, the RMU receives a digitalinstruction file containing instructions regarding fabrication of amedical device, and then begins manufacturing of the device. Asdiscussed above, the device could be manufacture by the RMU using anysuitable manufacturing technique, including, but not limited to,additive manufacturing, subtractive manufacturing, 3D printing, etc. Instep 144, when manufacturing of the device has been initiated, thesystem sends an update to a system operator, hospital personnel, and/orthe patient, advising that the manufacturing process has begun. In step146, after the RMU fabricates the device, an optional stress relief testcould be conducted by the RMU on the device. In step 148, the deviceundergoes a preliminary cleaning by the RMU to remove debris from thedevice. Then, in step 150, the RMU scans the device to ascertain that itcomplies with pre-defined quality control standards. This could beaccomplished using laser scanning or other type of non-contact scanningof the device.

In step 152, the RMU transmits a quality scanning report to the centralcontrol system 20. Then, in step 154, the RMU determines whether themanufactured device deviates from pre-defined quality control standards.If a positive determination is made, step 156 occurs, wherein adeviation notification is transmitted to the central control system 20for review by one or more personnel (e.g., engineering staff, qualitycontrol personnel, etc.) Otherwise, steps 166-172, discussed below,occur.

In step 158, the RMU halts manufacturing of the device, and theaforementioned personnel are allowed to review the deviationnotification. In step 160, a determination is made as to whether thedeviation is tolerable and/or can be rectified using additionalmanufacturing steps. If a negative determination is made, step 162occurs, wherein the device is scrapped (e.g., it could be thrown awayentirely by the RMU, or its materials could be recycled by the RMU forfuture use by the system). If a positive determination is made, step 164occurs, wherein the RMU re-processes the device to correct thedeviation. This step could be carried out by the RMU itself, or usingother devices such as milling machines, lathe machines, grindingmachines, etc., any of which could be in communication with and/orcontrolled by the RMU. Next, in step 166, once the device has beensuccessfully re-processed, a final cleaning of the device is performedby the RMU. Then, in step 170, the RMU sterilizes the device using anysuitable sterilization technique such as ultraviolet, steam, hydrogenperoxide, ethylene oxide (ETO) or other sterilization technique.Finally, once the device has been successfully sterilized, it istransferred to the packaging unit (subsystem) 38 of the RMU, forpackaging of the device.

FIG. 8 is a flowchart showing processing steps 180 carried out by thesystem for periodic calibration of the remote manufacturing unit of thesystem. Periodic calibration of the RMU is performed to ensure that theRMU is appropriately calibrated and continues to function withinacceptable parameters. In step 182, the RMU manufactures a calibrationtesting part, such as a sample medical device that will only be used bythe RMU for calibration purposes. Then, in step 184, the RMU measuresthe testing part and compares the measurement data to pre-definedcalibration data. In step 186, a determination is made as to whethercalibration is necessary. If so, step 188 occurs, wherein the systemtransmits a calibration notice to repair/maintenance personnel,requesting servicing/calibration of the RMU.

FIG. 9 is a diagram illustrating hardware and software components of theremote manufacturing unit controller 30 of the system. The processingsteps carried out by the RMU and discussed above could be embodied asone or more control engines/software modules 190 that are stored in anon-volatile storage device 192 of the controller 30 (including, but notlimited to, disk memory, flash memory, read-only memory (ROM), or othertype of non-volatile memory) and executed by a central processingunit/microprocessor 198 of the controller 30. A network interface 194 isprovided for allowing the controller to communicate with one or moreexternal devices (e.g., one or more of the components/devices discussedabove in connection with FIGS. 1-2). An internal bus 196 allows forinter-communication between the components of the controller 30 shown inFIG. 9. Also provided in the controller 30 is a random-access memory(RAM) 200, a subsystem communication interface 202 (for allowingcommunication with an external controller bus, such as an RS-485 bus), adisplay 204, and one or more input devices 206 (e.g., keyboard,touchscreen, mouse, trackball, track pad, etc.).

FIG. 10 is a diagram illustrating hardware and software components ofthe central control system 20 of the system. The processing stepscarried out by the central control system 20 and discussed above couldbe embodied as one or more control engines/software modules 210 that arestored in a non-volatile storage device 212 of the control system 20(including, but not limited to, disk memory, flash memory, read-onlymemory (ROM), or other type of non-volatile memory) and executed by acentral processing unit/microprocessor 218 of the control system 20. Anetwork interface 214 is provided for allowing the control system 20 tocommunicate with one or more external devices (e.g., one or more of thecomponents/devices discussed above in connection with FIG. 1). Aninternal bus 216 allows for inter-communication between the componentsof the control system 20 shown in FIG. 10. Also provided in the controlsystem 20 is a random-access memory (RAM) 220, a display 204, and one ormore input devices 206 (e.g., keyboard, touch-screen, mouse, trackball,track pad, etc.).

FIG. 11 is a diagram illustrating hardware and software components ofone of the smart phones 26 of FIG. 1. The processing steps carried outby the smart phone 26 and discussed above could be embodied as one ormore doctor/patient portal engines/software applications that are storedin a non-volatile storage device 232 of the smart phone 26 (including,but not limited to, disk memory, flash memory, read-only memory (ROM),or other type of non-volatile memory) and executed by a centralprocessing unit/microprocessor 238 of the smart phone 26. A networkinterface 234 is provided for allowing the smart phone 26 to communicatewith one or more external devices (e.g., one or more of thecomponents/devices discussed above in connection with FIG. 1). Aninternal bus 236 allows for inter-communication between the componentsof the smart phone 26 shown in FIG. 11. Also provided in the smart phone26 is a random-access memory (RAM) 240, a display 242, and one or moreinput devices 244 (e.g., touch-screen, etc.).

It is noted that the RMU of the system could be augmented to include oneor more subsystems for recycling of used medical devices previouslyfabricated by the RMU, thereby saving materials costs and reducingwaste. In such circumstances, the RMU would include the ability toprocess such materials (e.g., by way of mechanical grinding, melting,etc.) and to remove biohazards from such materials, prior to re-usage ofthe materials to fabricate new devices. Also, it is contemplated thatthe RMU of the system includes the ability to monitor the supply of rawmaterials presently available to the RMU for device manufacturingpurposes, and to generate and transmit periodic requests to replenishsuch materials.

As can be appreciated from the foregoing discussion, the system of thepresent invention provides a flexible, distributed platform for allowingmedical devices to be rapidly manufactured at facilities in response toremote and/or local requests for such devices, e.g., over the Internetusing one or more of the computing devices discussed above and/or at afacility using a kiosk-type computing device. Further, while mention hasbeen made above in connection with manufacturing being conducted atmedical facilities, it is to be understood that the system of thepresent invention could be implemented to remotely manufacture devicesat other locations, such as at regional and/or remote manufacturingsites, and/or at locations to which RMV could be shipped and set up foroperation.

Having thus described the system and method in detail, it is to beunderstood that the foregoing description is not intended to limit thespirit or scope thereof. It will be understood that the embodiments ofthe present disclosure described herein are merely exemplary and that aperson skilled in the art may make any variations and modificationwithout departing from the spirit and scope of the disclosure. All suchvariations and modifications, including those discussed above, areintended to be included within the scope of the disclosure. What isdesired to be protected by Letters Patent is set forth in the appendedclaims.

What is claimed is:
 1. A system for manufacturing medical devices,comprising: a manufacturing unit installed at a medical facility havingan operating room for performing a medical procedure, the manufacturingunit including: a manufacturing subsystem for manufacturing medicaldevices; a finishing subsystem for finishing medical devicesmanufactured by the manufacturing subsystem; and a controller forcontrolling the manufacturing subsystem and the finishing subsystem; atleast one computer system in communication with the manufacturing unit,the at least one computer system comprising a processor and a memorydevice, the memory device including instructions that, when executed bythe processor, perform operations including: presenting a healthcareprofessional with a digital catalog of medical devices, allowing thehealthcare professional to select a desired device from the digitalcatalog of medical devices for use during an operation in the operatingroom, and transmitting instructions for manufacturing the selecteddevice to the manufacturing unit at the medical facility, for subsequentmanufacturing of the selected device by the manufacturing unit; whereinthe at least one computer system comprises a kiosk-type computerinstalled at the medical facility at a location within the medicalfacility remote from the manufacturing unit; and a central controlsystem in communication with the at least one computer system and themanufacturing unit at a location remote from the medical facility;wherein the central control system remotely controls manufacturingprocesses carried out by the manufacturing unit.
 2. The system of claim1, wherein the manufacturing subsystem of the manufacturing unitfabricates the desired medical device using at least one of athree-dimensional printer, an additive manufacturing technique and asubtractive manufacturing technique.
 3. The system of claim 1, whereinthe finishing subsystem comprises a cleaning subsystem for cleaningdevices manufactured by the manufacturing unit.
 4. The system of claim1, wherein the finishing subsystem comprises a sterilization subsystemfor sterilizing devices manufactured by the manufacturing unit.
 5. Thesystem of claim 1, wherein the finishing subsystem comprises a packagingsubsystem for packaging devices manufactured by the manufacturing unit.6. The system of claim 1, wherein the finishing subsystem comprises arobot integration subsystem.
 7. The system of claim 1, wherein thefinishing subsystem comprises an inspection subsystem for inspectingdevices manufactured by the manufacturing unit.
 8. The system of claim1, wherein the manufacturing unit recycles used medical devices for usein manufacturing future medical devices.
 9. The system of claim 1,wherein the finishing subsystem comprises: a packaging subsystem forpackaging devices manufactured by the manufacturing subsystem aftersterilizing; and a delivery system for delivering a packaged medicaldevice to a hospital materials distribution system within the medicalfacility.
 10. The system of claim 1, wherein the manufacturingsubsystem, the finishing subsystem and the controller are located in asingle common housing.
 11. The system of claim 1, wherein the at leastone computer system is in communication with a hospital informationmanagement system of the medical facility.
 12. The system of claim 1,wherein the memory device includes further instructions that, whenexecuted by the processor, perform further operations including:presenting a healthcare professional with a digital catalog of medicaldevices, allowing the healthcare professional to select a desired devicefrom the digital catalog of medical devices, presenting the healthcareprofessional with a model of the desired device and allowing thehealthcare professional to customize the desired device prior tomanufacturing of the device, and transmitting instructions formanufacturing a customized device to the manufacturing unit at themedical facility, for subsequent manufacturing of the customized deviceby the manufacturing unit.
 13. A system for manufacturing medicaldevices, comprising: a manufacturing unit installed at a medicalfacility, the manufacturing unit including: a manufacturing subsystemfor manufacturing medical devices; a first finishing subsystem forperforming a first finishing procedure on medical devices manufacturedby the manufacturing subsystem; a second finishing subsystem forperforming a second finishing procedure on medical devices manufacturedby the manufacturing subsystem; a robot subsystem for movingmanufactured medical devices between the manufacturing subsystem, thefirst finishing system and the second finishing system; a controller forcontrolling the manufacturing subsystem and the first and secondfinishing subsystems; a packaging subsystem for packaging devicesmanufactured by the manufacturing subsystem after sterilizing, whereinthe packaging subsystem includes a delivery system for delivering apackaged medical device to a hospital materials distribution systemwithin the medical facility; and at least one computer system incommunication with the manufacturing unit, the at least one computersystem configured to allow a healthcare professional to input a desiredmedical device for manufacturing, and configured to transmitinstructions for manufacturing the desired medical device to themanufacturing unit at the medical facility, for subsequent manufacturingof the desired medical device by the manufacturing unit.
 14. The systemof claim 13, wherein: the first finishing subsystem comprises aninspection subsystem for inspecting devices manufactured by themanufacturing unit; and the second finishing subsystem comprises asterilizing subsystem for sterilizing devices manufactured by themanufacturing unit.
 15. The system of claim 14, wherein the inspectionsubsystem comprises a non-contact scanning device.
 16. The system ofclaim 14, wherein the sterilizing subsystem includes at least one of anultraviolet sterilizing system, a steam sterilizing system, a hydrogenperoxide sterilizing system and an ethylene oxide sterilizing system.17. The system of claim 14, further comprising a cleaning subsystem forcleaning devices manufactured by the manufacturing unit beforeinspection.
 18. The system of claim 14, further comprising a scrappingsubsystem for recycling devices after inspection.
 19. The system ofclaim 18, wherein the scrapping subsystem includes a mechanical grindingsystem or a melting system.
 20. A system for manufacturing medicaldevices, comprising: a first manufacturing unit installed at a firstmedical facility, the first manufacturing unit including: amanufacturing subsystem for manufacturing medical devices; a finishingsubsystem for finishing medical devices manufactured by themanufacturing subsystem; and a controller for controlling themanufacturing subsystem and the finishing subsystem; wherein themanufacturing subsystem, the finishing subsystem and the controller arelocated in a single common housing; at least one computer systeminstalled at the first medical facility at a location in the firstmedical facility different than the first manufacturing unit so as to bein communication with the first manufacturing unit and a hospitalinformation management system of the first medical facility, the atleast one computer system comprising a processor and a memory device,the memory device including instructions that, when executed by theprocessor, perform operations including: presenting a healthcareprofessional with a digital catalog of medical devices, allowing thehealthcare professional to select a desired device from the digitalcatalog of medical devices, presenting the healthcare professional witha model of the desired device and allowing the healthcare professionalto customize the desired device prior to manufacturing of the device,and transmitting instructions for manufacturing a customized device tothe manufacturing unit at the first medical facility, for subsequentmanufacturing of the customized device by the first manufacturing unit;and a central control system installed remotely from the medicalfacility so as to be discrete from and in communication with both the atleast one computer system and the first manufacturing unit, wherein thecentral control system supplies a plurality of product designs forviewing at the at least one computer system.
 21. The system of claim 20,further comprising a second manufacturing unit installed at a secondmedical facility, the second manufacturing unit in communication withthe central control system.